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Mindfulness Meditation and Bariatric Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04167852
Recruitment Status : Recruiting
First Posted : November 19, 2019
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Maggie Diller, Cedars-Sinai Medical Center

Brief Summary:
This study represents a 3-arm, randomized controlled trial to investigate the impact of a validated 10-minute mindfulness intervention delivered via mobile technology on postoperative bariatric patients. The investigators hypothesize that participation in a brief, daily mindfulness intervention will improve outcomes in bariatric patients and use of mobile technology will facilitate patient compliance.

Condition or disease Intervention/treatment Phase
Opioid Use Bariatric Surgery Candidate Pain, Postoperative Behavioral: Daily text message Behavioral: Mindfulness intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: A Randomized, Prospective Investigation of a Brief, Daily Mindfulness Intervention for Postoperative Bariatric Patients
Actual Study Start Date : November 21, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment group
Subject to receive daily short message service (SMS) text message with a link to a mindfulness intervention.
Behavioral: Daily text message
Patients will receive a daily text message stating how many days they have until or since their surgery.

Behavioral: Mindfulness intervention
Patients will receive a link to mindfulness meditation intervention for ten minutes.

Experimental: Text group
Subject to receive daily text message but without the link to the mindfulness intervention.
Behavioral: Daily text message
Patients will receive a daily text message stating how many days they have until or since their surgery.

No Intervention: Standard of Care group
Subject will not receive any text message reminders or the mindfulness meditation intervention.



Primary Outcome Measures :
  1. Daily post-operative patient reported pain scores [ Time Frame: 30 days after discharge ]
    Daily post-operative patient reported pain scores via the validated Numeric Rating Scale (NRS). The higher number indicates more pain.

  2. Daily post-operative narcotic consumption [ Time Frame: 30 days after discharge ]
    Daily post-operative narcotic consumption reported as morphine equivalent dose (MED).


Secondary Outcome Measures :
  1. Patient satisfaction: (HCAHPS) scores [ Time Frame: visit 3 (4 weeks after operation) ]
    Patient satisfaction as determined by hospital consumer assessment of healthcare providers and services (HCAHPS) scores. HCAHPS is broken down into percentiles and then categorized into "boxes". The higher the percent the more positive the response. The top box is the most positive category, middle box is in-between, and the bottom box is the least positive.

  2. Weight loss [ Time Frame: pre operation, visit 3 (4 weeks after operation), 3 months, 6 months, 12 months ]
    Weight loss (expressed by % excessive BMI loss)

  3. Bariatric-specific quality of life (BQL) [ Time Frame: pre operation, visit 3 (4 weeks after operation), 3 months, 6 months, 12 months ]
    Bariatric-specific quality of life (BQL). BQL ranges from 14-78 with higher scores representing a better quality of life.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients > 18 years of age
  2. BMI > 40 or a BMI > 35 with the presence of at least 1 comorbidity (hypertension, diabetes, sleep apnea syndrome, coronary artery disease, dyslipidemia, osteoarthritis, secondary infertility in females)
  3. Ownership of smart phone (iOS or Android operating system) with SMS text messaging capabilities
  4. Ability to read and understand English
  5. Ability to understand the purposes and risk of the study and willingly give standard written informed consent for treatment established by Cedars Sinai Medical Center

Exclusion Criteria:

  1. Patients with contraindications to abdominal surgery and/or general anesthesia
  2. Patients will be screened for PTSD preoperatively. Patients with diagnosable PTSD will be excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04167852


Contacts
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Contact: Maggie Diller, MD 424-261-9123 Maggie.Diller@cshs.org

Locations
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United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Maggie Diller, MD    424-261-9123    Maggie.Diller@cshs.org   
Principal Investigator: Maggie Diller, MD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Maggie Diller, MD Cedars-Sinai Medical Center
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Responsible Party: Maggie Diller, Principal Investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT04167852    
Other Study ID Numbers: IIT2019-DILLER-MM
First Posted: November 19, 2019    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maggie Diller, Cedars-Sinai Medical Center:
Pain
postoperative
meditation
opioid use
bariatric
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms